Not currently registered with FDA under this name
Astra Tech AB
San Diego, CA, United States. Named as applicant on 33 dental 510(k) clearances between 1994 and 2013. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 331994–2013
- Markets registered in
- 234 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Astra Tech AB as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Astra Tech AB | 33 clearances | 1994–2013 | Below |
| South Korea | MFDS | Manufacturer | Astra Tech ABASTRA TECH AB | 34 | 1999–2004 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Astra Tech AB as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Jan 2013 | K121810 | OSSEOSPEED ANGLED ABUTMENT EV | NHA Endosseous Dental Implant Abutment |
| 31 Jul 2012 | K120414 | OSSEOSPEED PLUS | DZE Root-Form Endosseous Implant |
| 5 Jul 2012 | K120338 | ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA | NHA Endosseous Dental Implant Abutment |
| 1 Mar 2012 | K113003 | ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... | NHA Endosseous Dental Implant Abutment |
| 1 Dec 2011 | K112138 | ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT | NHA Endosseous Dental Implant Abutment |
| 26 Sep 2011 | K111287 | ASTRA TECH IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 21 Jun 2011 | K101005 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | NHA Endosseous Dental Implant Abutment |
| 10 Jun 2011 | K110640 | ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 10 Jun 2011 | K110356 | ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 8 Apr 2011 | K103759 | ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT | NHA Endosseous Dental Implant Abutment |
| 23 Feb 2011 | K101732 | ASTRA TECH IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 16 Aug 2010 | K101004 | ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 16 Apr 2010 | K093780 | ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 22 Dec 2009 | K093483 | ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 28 Sep 2009 | K091920 | ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL | NHA Endosseous Dental Implant Abutment |
| 22 Sep 2009 | K091239 | ASTRA TECH IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 15 Apr 2009 | K083871 | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE | NHA Endosseous Dental Implant Abutment |
| 7 Oct 2008 | K081666 | ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS | NHA Endosseous Dental Implant Abutment |
| 17 Sep 2008 | K080156 | OSSEOSPEED TM PROFILE SYSTEM | DZE Root-Form Endosseous Implant |
| 30 Apr 2008 | K080396 | OSSEOSPEED NARROW | DZE Root-Form Endosseous Implant |
| 1 Oct 2007 | K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | NHA Endosseous Dental Implant Abutment |
| 27 Apr 2007 | K063779 | OSSEOSPEED 4.0S-6MM, MODEL 24619 | DZE Root-Form Endosseous Implant |
| 24 Mar 2006 | K053384 | FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 9 Aug 2004 | K041492 | ASTRA TECH IMPLANTS - DENTAL SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Jun 2003 | K024111 | ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED | DZE Root-Form Endosseous Implant |
| 7 Nov 2002 | K023631 | ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 4 Jan 2001 | K002513 | ASTRA TECH IMPLANTS - DENTAL SYSTEM | DZE Root-Form Endosseous Implant |
| 15 Jul 1999 | K990304 | MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM | DZE Root-Form Endosseous Implant |
| 25 Jun 1999 | K991053 | ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO) | DZE Root-Form Endosseous Implant |
| 19 Nov 1998 | K974738 | ASTRA TECH IMPLANT DENTAL SYSTEM | DZE Root-Form Endosseous Implant |
| 24 Mar 1998 | K974737 | ASTRA TECH IMPLANT DENTAL SYSTEM | DZE Root-Form Endosseous Implant |
| 19 Mar 1998 | K980698 | ASTRA TECH IMPLANTS - DENTAL SYSTEM | DZE Root-Form Endosseous Implant |
| 8 Feb 1994 | K931767 | ASTRA TECH IMPLANTS-DENTAL SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (23).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.